MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Therapeutic Response, Decreased (2271); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Other relevant device(s) are : product id: 435135, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 27-apr-2013, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 27-apr-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider( hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient was doing well but symptoms came and egd confirmed dislodgement of electrodes protruding into the lumen of the stomach.Impedance were greater- 5792 and voltage was 7.5.Device was removed and issue was resolved without sequalae.No further complications were reported/anticipated at this time.

Manufacturer Narrative

H3: product analysis#: (b)(4): analysis information: 2021-02-01 07:18:22 cst pli#: 10, product id#: 3116.Below is the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.Analysis determined that the implantable neurostimulator (ins) output and telemetry were acceptable; however, the battery was near normal battery depletion.Product id: 435135, lot#serial#: (b)(6), implanted: on (b)(6) 2012, product type: lead, product id: 435135, lot#serial#: (b)(6), implanted: on (b)(6) 2012, product type: lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

No new information.

Manufacturer Narrative

Continuation of d10: product id: 435135; lot# serial#: (b)(6); implanted: on (b)(6) 2012; explanted: on (b)(6) 2019; product type: lead; product id: 435135; lot# serial#: (b)(6); implanted: on (b)(6) 2012; explanted: on (b)(6) 2019; product type: lead; h6: device code a072201 and patient code e2403 no longer apply to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information was received from a health care professional (hcp).In response to the inquiry for if the cause of the high impedance and lead dislodgement had been determined and what most likely caused or contributed to the issue, the hcp replied the impedance was 579 not 5792.What was interpreted as a 2 before was actually the symbol for ohms.The hcp clarified this in their reply.The impedance was 579 ohms and the lead dislodgement was related to trauma: the patient fell down and hit their abdomen on a bathtub which the hcp noted had been included in the original report.Previously omitted information on the report stated the patient had been doing well for many years and they hit the abdomen on a hard subject (which the hcp clarified in their reply as a bathtub).Also omitted was that the patient was re-implanted with ¿ges¿ on (b)(6) 2019 and was doing very well.The hcp had no technical/clinical problems to report.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10607507
• MDR Text Key: 209230957
• Report Number: 3004209178-2020-16969
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."; "SEE H10."
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 77